EDA Guidance on Preclinical Testing and Clinical Investigations: Overview

Table of content

The Egyptian Drug Authority (EDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to preclinical testing and clinical investigation for medical devices. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance. 

At the same time, it is important to mention that provisions of the guidance are non-binding in their legal nature, nor they are intended to introduce new rules or impose new obligations. Moreover, recommendations provided in the guidance could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.

Introduction

First of all, the authority mentions that medical devices differ from drugs primarily in their mechanism of action, operating through physical or mechanical means rather than relying on metabolic processes. 

These devices are defined broadly to include instruments, apparatuses, software, implants, reagents, and other tools intended for purposes such as:

• Diagnosis, prevention, and treatment of diseases or injuries
• Anatomical and physiological support
• Contraception
• Sterilization
• In vitro examination of biological specimens

They do not achieve their primary effect via pharmacological, immunological, or metabolic means but may be assisted by such mechanisms. 

Conformity assessment ensures that a medical device complies with safety, performance, and regulatory requirements. This process examines technical documentation, manufacturing protocols, risk analyses, clinical evidence, and post-market monitoring.

Scope

This guidance is aimed at stakeholders involved in preclinical and clinical studies for medical devices. 

It addresses two major categories:

1. Therapeutic and aesthetic devices (e.g., CPAP machines, IPL devices)
2. Diagnostic devices (e.g., glucose monitoring systems)

The document outlines requirements for medical devices under various scenarios:

• Locally manufactured devices
• Imported devices without international quality certification
• Marketed devices undergoing evaluation for new uses, populations, materials, or design changes
• Other cases requiring preclinical and clinical testing per regulatory mandates

Additionally, this guidance covers combination products (devices incorporating drugs or biologics) and Software as a Medical Device (SaMD). The principles align with existing laws, such as Clinical Trials Law 214/2020, relevant ISO standards (e.g., ISO 10993, ISO 14155-2020), and EDA clinical trial oversight guidelines.

Key Sections

The guidance document elaborates on six critical aspects of investigational medical devices:

1. Medical Device Classification: Classification is crucial for understanding the regulatory pathway and conformity requirements for specific device types.
2. Preclinical Investigations: This section highlights the significance of preclinical studies and animal testing to assess device safety, biocompatibility, and functionality.
3. Clinical Investigations: These are systematic studies involving human subjects to evaluate safety, clinical performance, and effectiveness.
4. Ethical Considerations: Protecting participants’ rights, safety, and well-being is emphasized, ensuring that studies adhere to ethical principles.
5. Safety Reporting: Guidelines for reporting adverse device effects (ADEs), serious adverse device effects (SADEs), and unanticipated serious adverse device effects (USADEs) are detailed to maintain vigilance during clinical investigations.
6. Risk Management: Risk assessment and management protocols are established to minimize residual risks and ensure device safety.

Terms and Definitions 

In order to assist the parties involved with interpreting the applicable regulatory requirements, the document includes a comprehensive list of abbreviations and definitions, such as:

• ADE/SADE/USADE: Refers to adverse effects of devices, including unanticipated ones.
• Conformity Assessment: A systematic evaluation to ensure devices meet essential safety and performance principles.
• Clinical Investigation Plan (CIP): Document detailing the study design, objectives, and methodologies.
• ISO Standards: International standards (e.g., ISO 14971-2019) providing frameworks for risk management, clinical investigations, and biocompatibility.

Conformity Assessment Details

According to the guidance, conformity assessment involves several stages:

• Technical Documentation: Details design specifications and manufacturing protocols.
• Risk Analysis: Evaluates potential hazards and their mitigation.
• Clinical Evidence: Demonstrates safety and effectiveness through data.
• Monitoring Procedures: Ensures continued compliance and vigilance post-market.

Manufacturers must demonstrate conformity to regulatory authorities like the Egyptian Drug Authority through comprehensive documentation and evidence submission. This ensures devices are safe and perform as intended.

Device-Specific Guidance

As further explained by the EDA, special considerations apply to certain devices:

• Combination Products: These integrate drugs, biologicals, or other ancillary components.
• Software as a Medical Device (SaMD): Software that functions independently or in conjunction with hardware to perform medical tasks.

The guidelines integrate ISO standards and local regulations to maintain consistency and reliability.

Ethical Oversight

Ethics committees (ECs) play a vitally important role in ensuring clinical studies respect participants’ rights and adhere to established ethical norms. Vulnerable populations, such as individuals unable to fully comprehend the investigation, require special attention to avoid undue influence.

Safety and Risk Considerations

When it comes to the risks associated with medical devices, the document emphasizes the following aspects:

• Risk Management: Systematic approaches to analyze, evaluate, and control risks.
• Safety Reporting: Mechanisms for identifying and addressing device deficiencies, adverse events, and field safety corrective actions (FSCAs).

The above principles are intended to protect users, patients, and other stakeholders.

Conclusion

In summary, the guidance provides a structured approach to the preclinical and clinical evaluation of medical devices, ensuring compliance with regulatory standards and prioritizing safety and performance.

Source

https://www.edaegypt.gov.eg/media/lm0odsj1/guide-line-medical-deviece-guideline.pdf

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